Vascular access port

ABSTRACT

An access port, wherein the access port may include a body having an exterior surface and a chamber defined therein, a bore defined in the body providing fluid communication between the chamber and the exterior surface, a needle in fluid communication with the chamber, a passage defined in the body providing communication between the chamber and the exterior surface, a seal secured within the passage, and an actuator in communication with the needle, configured to move the needle relative to the passage or move the passage relative to the needle.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/267,537 filed Sep. 16, 2017, which is a continuation of U.S. patentapplication Ser. No. 13/770,732 filed Feb. 19, 2013, now U.S. Pat. No.9,480,831, which is a continuation of U.S. patent application Ser. No.12/631,268, filed Dec. 4, 2009, now U.S. Pat. No. 8,377,034, the entiredisclosure of each of which is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to vascular access port and, inparticular, to a sub-cutaneous vascular access port that may include aneedle that penetrates the skin, wherein the needle may extend orretract from the housing, or the housing may expand and/or collapsearound the needle.

BACKGROUND

Hematology patients, oncology patients, hemodialysis patients and otherpatients may be subject to frequent infusion treatments deliveringpharmaceuticals, blood, nutrients, contrasting agents and othercompositions. Frequent “needle sticks” and the duration of infusion timemay make receiving such treatments uncomfortable. Vascular access portsare medical devices that may be inserted beneath the skin and may reducethe discomfort associated with such treatments. A port may include anaccess point, such as a septum, into which a needle may be inserted. Aport may also include a catheter, which may be inserted into a vein,such as a jugular vein, subclavian vein or superior vena cava. Theseptum may be formed of a self-healing silicone material that may bepunctured multiple times with a relatively low loss in its integrity.However, a clinician needs to properly target the access port and a riskof infection may exist as a needle extending into the skin may dragbacteria from the skin into the port.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features of this disclosure, and themanner of attaining them, may become more apparent and better understoodby reference to the following description of embodiments describedherein taken in conjunction with the accompanying drawings, wherein:

FIG. 1a illustrates a cross-sectional view of an example of a vascularaccess port contemplated herein, with the needle in the retractedposition;

FIG. 1b illustrates a cross-sectional view of an example of a vascularaccess port contemplated herein, with the needle in the extendedposition;

FIG. 2a illustrates a cross-sectional view of an example of a vascularaccess port contemplated herein, with the needle in the retractedposition;

FIG. 2b illustrates a cross-sectional view of an example of a vascularaccess port contemplated herein, with the needle in the extendedposition;

FIG. 3a illustrates a cross-sectional view of an example of a vascularaccess port contemplated herein, with the needle in the retractedposition;

FIG. 3b illustrates a cross-sectional view of an example of a vascularaccess port contemplated herein, with the needle in the extendedposition;

FIG. 4 illustrates a schematic of a control system for a vascular accessport;

FIG. 5a illustrates a cross-sectional view of an example of a vascularaccess port contemplated herein, with the needle in the retractedposition;

FIG. 5b illustrates a cross-sectional view of an example of a vascularaccess port contemplated herein, with the needle in the extendedposition;

FIG. 6a illustrates a cross-sectional view of an example of a vascularaccess port contemplated herein, with the needle in the retractedposition;

FIG. 6b illustrates a cross-sectional view of an example of a vascularaccess port contemplated herein, with the needle in the extendedposition;

FIG. 7a illustrates a cross-sectional view of an example of a vascularaccess port contemplated herein, with the needle in the retractedposition; and

FIG. 7b illustrates a cross-sectional view of an example of a vascularaccess port contemplated herein, with the needle in the extendedposition.

DETAILED DESCRIPTION

It is to be understood that this disclosure is not limited in itsapplication to the details of construction and the arrangement ofcomponents set forth in the following description or illustrated in thedrawings. The embodiments herein are capable of other embodiments and ofbeing practiced or of being carried out in various ways. Also, it is tobe understood that the phraseology and terminology used herein is forthe purpose of description and should not be regarded as limiting. Theuse of “including,” “comprising,” or “having” and variations thereofherein is meant to encompass the items listed thereafter and equivalentsthereof as well as additional items. Unless limited otherwise, the terms“connected,” “coupled,” and “mounted,” and variations thereof herein areused broadly and encompass direct and indirect connections, couplings,and mountings. In addition, the terms “connected” and “coupled” andvariations thereof are not restricted to physical or mechanicalconnections or couplings.

The present invention relates generally to vascular access port and, inparticular, to a sub-dermal vascular access port that includes anextendable/retractable needle or a body portion that is collapsible andexpandable, configured to expose the needle upon collapsing. The needlemay puncture through the subject's skin, providing access to the port. Acatheter or other device may be affixed to the needle to provide acomposition to the subject or the needle may puncture a vial stopper anda composition stored in the vial.

FIGS. 1a and 1b illustrate examples of a vascular access port includinga needle in the retracted and extended positions. The access port body100 may generally include a chamber 102 defined in the port and anexternal surface 104. The port may also include a bore 106 connecting orproviding fluid communication between the chamber and the externalsurface of the port. A passage 108 may also be provided between thechamber and an external surface of the port. A needle 110 may bepositioned within the passage 108 and may extend and/or retract from thebody relative to a seal (or septum described below). The needle 110 mayinclude a shaft 112, a distal end 114 and a proximal end 116. Inaddition, the needle 110 may be made of a ferromagnetic material, or mayinclude a ferromagnetic material at the distal end 114.

To extend the needle, a magnet M may be passed over the needle or may bepositioned on the device to which the needle may attach. The needle,being attracted to the magnet may extend from the access port towardsthe magnet. In some examples, rotation of the needle may lock the needlein place. For example, the proximal end of the needle may include aprojection 120 that may slide into a catch or channel 122 provided inthe chamber at a given height. The needle may be retracted by releasingthe magnet (i.e., moving the magnet away from the needle). In addition,the magnet may be positioned on or within the device to which the needlemay be affixed to administer a given composition. For example, themagnet may be positioned proximal to the lip of a vial, near the vialstopper, or in the tip of a catheter into which the needle may beasserted.

In addition, a spring 124 may be positioned between the proximal end ofthe needle and a chamber wall 126 to retain the needle in the retractedposition. As may be appreciated the force exerted by the spring S on theneedle towards the retracted position may be less than the force exertedby the magnet M, wherein M>S. In one example, the needle may include aflare 128 at the proximal end accommodating the spring. In addition, abumper 130 may be provided to receive the distal end of the needle inthe retracted position to prevent back flow of fluid through the needleand out of the access port. The bumper may be formed into the chamber ormay be adhered onto the chamber walls.

In some examples, a seal or septum 132 may be provided at the upperportion of the passage 108. This seal 132 may be provided alone or inaddition to the bumper 130 provided in the chamber 102. The seal 132 mayinclude a perforation 134 to allow the needle to more easily passthrough upon application of actuatuation force by an actuator, which maybe for example a magnetic force. In addition, an additional seal 136 maybe provided to prevent backflow of the fluid in the chamber into theneedle passage. It may be appreciated that further seals may be providedbetween the base of the passage 138 and the proximal end of the passage140. In other embodiments, an expandable and/or collapsible sleeve 142may be provided over the spring or needle preventing mingling of thefluids in the port with the spring surfaces or the exterior surfaces ofthe needle. The sleeve may be accordion like or in the shape of abellows.

A catheter 144 may be removably attached to the access port 100 by aconnector 146, or permanently attached to the access port throughchemical or mechanical means, including an adhesive, ultrasonic welding,press-fits, etc. The catheter may be relatively flexible and formed of acomposition such as silicone, polyurethane, or other thermoplasticelastomers. In addition, in some embodiments, a metering device 150 maybe provided between the chamber and the catheter. The metering devicemay include a valve and allow for control of the flow rate of fluid fromthe port into the vascular system.

In further examples, illustrated in FIGS. 2a and 2b , the vascularaccess port may include a retractable and extendable needle, retractedand expanded by a mechanical actuator. The access port body 200 mayagain generally include a chamber 202 defined in the part and anexternal surface 204. The port may include a bore 206 connecting orproviding fluid communication between the chamber and the externalsurface of the port. A passage 208 to accommodate the travel of theneedle 210 may be provided between the chamber and an external surfaceof the port. The needle 210 may include a shaft 212, a distal end 214and a proximal end 216.

The mechanical actuator 220 may include a mechanical linkage. In oneexample, a button 222 may be mechanically affixed to a lever 224, whichis affixed to the needle, by a first linkage 226. Upon pressing thebutton, the lever may rotate around a pivot point and raise the needlethrough the subject's skin. Other linkages may be envisioned and are notlimited to the linkage herein. Furthermore, a spring 228 may beprovided, such as under the button, which raises the button and therebywithdraws the needle. In other examples, the needle may be springloaded, biasing the needle into the retracted position. The button maybe directly pressed by a person providing a composition into the port.However, it may also be envisioned that the button may be pressed bypushing against it with a vial or other container including thecomposition to be provided to the subject.

In another example, as illustrated in FIGS. 3a and 3b , the vascularaccess port may include a needle that may be extended or retracted by anactuator that includes electrical/mechanical device. The access portbody 300 may include a chamber 302 defined therein as well as a bore 304that extends from the chamber to an exterior surface of the access port,providing communication between the interior (chamber) of the accessport and the external environment. In addition, the access port mayinclude a passage 306, which may accommodate the needle 308 as itextends or retracts with respect to a surface 301 on the body 300 of theaccess port.

The access port may also include a motor or other device that may extendor retract the needle. Motors may include linear piezoelectric orelectromagnetic motors. In some examples, the motor may be apiezoelectric micro-motor 309. The motor may include a linear traveler,such as a shaft or translator. In some examples, the shaft or translatormay interact with the needle translating the needle up and down relativeto the port body. In other examples, the shaft or linear translator maybe the needle, having a hollow cylinder defined therein.

In some examples, a processor 310 may be provided to power the motor andcontrol the direction of needle travel. The processor and motor may bepowered by a power supply 312. The power supply may communicateelectrically either directly or indirectly with either the processorand/or motor. For example, in some cases, the processor may providepower to the motor and in other cases a transformer may be providedeither between the power supply and processor and/or between the powersupply and the motor.

The processor may be actuated by an activator. In some examples, a“button” or other device may be provided that, when depressed orotherwise activated, may send a signal to the processor to actuate theneedle. In other examples, the port may include a communication device314 such as a receiver or transceiver, which may include a receiver. Thecommunication device may be configured to receive or transmit anelectromagnetic indicator, such as electromagnetic waves or signals suchas radio waves or optical waves, received from a wireless activator. Forexample, the communication device may receive radio waves from an RFID(radio frequency identification) device. The RFID device may beintegrated into a tag or card that when brought into proximity with theaccess port may activate the actuator (i.e., the processor) and causethe needle to extend from the access port body. In another example, thecommunication device may detect or receive optical signals. Such signalsmay be in the range of 200 nm to 900 nm, including all values andincrements therein, such as 200 nm to 400 nm (ultraviolet light), 380 nmto 750 nm (visible light), 750 nm to 1400 nm (infrared light). In someembodiments, the optical waves may exhibit a Fraunhofer wavelength,i.e., a wavelength not emitted by the sun, preventing accidentaltriggering of the device upon exposure to the sun. It may be appreciatedthat the radio or optical signals may be received or detected at asingle wavelength or at multiple wavelengths, including 1 wavelength to20 wavelengths and all values and increments therein. Other devices thatmay be used to cause the processor to actuate the motor may includewi-fi, Bluetooth or other transmitters or transceivers includingtransmitters, light. Furthermore, a light pen, or other light source maybe an activator for the processor to actuate the motor.

The electromagnetic indicators may be provided by a transmitter or atransceiver that may include a transmitter in the activator. Theelectromagnetic indicators may be pulsed or otherwise manipulated toprovide directions or instructions. For example, the indicators maysignal for the processor to extend the needle or retract the needle. Inother examples, the indicators may provide an identifier to preventcross-talk between devices or prevent accidental extension or retractionof the needle. The activator may also include a processor for regulatingthe signals from the transmitter, which may be in electricalcommunication with the processor.

Accordingly, it may be appreciated that a system may be providedincluding the vascular access port and an activator. An example of sucha system is illustrated in the schematic diagram of FIG. 4, wherein anactivator 400 may emit various electromagnetic signals or waves. Uponreceiving the electromagnetic waves, the receiver 410 may convert thewaves into electrical pulses that may be communicated to the processor412. Depending on the signals received, the processor may perform anumber of functions. In some examples, the processor may actuate themotor 414 to extend or retract the needle 415. In other examples, theprocessor may identify the received signals as being identifyinginformation that correlates the activator with the access port. Theprocessor may compare the identifying information with a lookup table oridentifying information stored in a memory device 416. If theidentifying information is correct, then the processor may employ anycommands that may be received from that device to extend or retract theneedle. It may be appreciated that identifying information may betransmitted a single time or multiple times, such as with each command.Upon receiving a signal to actuate the motor, i.e., extend or retractthe needle, the processor may send an electrical signal to the motor orprovide power to the motor from the power supply 418 such that the motorwill displace the linear traveler, extending or retracting the needle.

Returning again to FIGS. 3a and 3b , the body 300 may include a numberof seals that may isolate the chamber and the interior of the needle.For example, a first seal or set of seals 320 may be provided where theneedle extends into the chamber. The seal may prevent the compositionbeing injected into the port from flowing back into the passage. Inanother example, a septum 322 may be provided at the surface 301 of thebody. The needle 308 may penetrate the septum 322 when extended and theseptum may prevent fluids or other contaminants from entering the port.In addition, the septum may be formed from a self healing composition,such as silicone or natural rubber. In a further example, another set ofseals 324 may be provided near the surface 301 of the body, wherein theseal 324, like the septum, may prevent fluids or other contaminants fromentering the port.

The port may also include a connector 330, which may connect the bore304 leading into the chamber with a catheter 332. The connector mayinclude barbs 334 or other mechanical interlocks to retain the catheteron the port. However, it may be appreciated that, in some examples, thecatheter may be removed from the connector. In other embodiments, thecatheter may be welded to the port, permanently affixing the catheter tothe port.

In addition, as illustrated in the embodiment above, the chamber, e.g.,chamber 302 of FIG. 3, may be defined to assume different geometries.Accordingly, rather than assuming the geometry of a rather rectangularreservoir, the chamber may assume the shape of an ellipse, oval, circle,shaft or other geometric configurations. In addition, while the needleis illustrated as being positioned on a stopper in the retractedposition, it may be appreciated that the needle need not return againstanother object or may return against a wall of the chamber.

Furthermore, with reference to FIG. 3a and FIG. 3b , it may beappreciated that the bore may include a seal 336. The seal may allow forfluids to pass out of the bore from the chamber and into the connectorand/or catheter. However, in some examples, the seal may preventbackflow from the connector and/or catheter. For example, in oneembodiment, the seal may include a duckbill valve.

In a further embodiment, at least a portion of the access port body maymove relative to the needle, such that the needle may be fixed withregard to the chamber but may still move relative to the septum 522. Thebody may therefore collapse, exposing the needle or extend to cover theneedle. In one example, illustrated in FIG. 5a and FIG. 5b , the body500 may include a first portion 540 and a second portion 542. To locatethe first portion of the body relative to the second portion of thebody, the first portion of the housing 540 may include a first wall 544extending from the main segment 546 of the first portion of the body500. In addition, the second portion 542 of the housing may include asecond wall 548 and a support member 550. The first wall 544 may bereceived in a sliding manner between the second wall 548 and the supportmember 550.

The first portion 540 may also include one or more tabbed latches 552also extending form the main segment of the first portion around theperiphery of the housing, which may hold the body in a first expandedposition as illustrated in FIG. 5a . The tabbed latch may be received ina recess 554 provided by a support member 550 found in the secondportion 542 of the body. When the access port body 500 is held in thefirst expanded position, the needle 508 may be completely orsubstantially contained within the access port body 500.

When collapsed, through the application of force on the body, the needle508 which may be held in a fixed position relative to the second portion542 of the body may perforate and extend through the septum 522, asillustrated in FIG. 5b . In addition, the first wall 544 of the firstportion may slide towards the main segment 556 of the second portionbetween the second wall 548 and the support member 550. The body may bemaintained in a collapsed positioned through continuous application ofpressure. A spring 524 may also be provided which may raise the firstportion of the body 540 back to the first expanded position asillustrated in FIG. 5 a.

A chamber 502 may be provided within the access port body 500 andmounted to or provided within, for example, the second portion of thebody 542. In some examples, the needle 508 may be fixedly mounted to thechamber 502. While it is illustrated in FIGS. 5a and 5b that the needlemay extend into the chamber 502, the needle may also be provided flushwith the chamber 502. In some examples, the needle may be integratedinto the chamber 502 or access port body 500. Furthermore, in someexamples, the needle 508 may include threads or another mechanicalinterlock allowing for the needle to be removed from either the chamber502 or access port body 500 for replacement.

FIGS. 6a and 6b illustrate an example, wherein the first and secondportions 640, 642 of the access port body 600 may be extended orretracted by an actuator that includes an electrical/mechanical device.The access port may include a motor or other device that may expand orcollapse the housing 609. In some examples, the motor may include apiezoelectric micro-motor 609. The motor 609 may include a lineartraveler 660, such as a shaft or a translator that may interact with acylinder 662 provided in the housing, moving the housing halves 640, 642relative to each other. It may be appreciated that the cylinder need notbe a tube having a complete wall, for example, slots may be provided inthe wall. The linear traveler 660 may include, for example, a set ofexternal threads, which may interact with a set of internal threadsprovided on the cylinder 662.

As the linear traveler rotates, the cylinder 662 and one of theportions, to which the cylinder is mounted may move relative to theother portion. When linear traveler rotates in one direction, the bodymay collapse, wherein the needle 608 may pass through the septum 622 andmay be exposed. When the traveler rotates in the other direction, thebody may expand, wherein the needle 608 may be pulled back through theseptum 622 and covered. As illustrated, the motor is mounted the secondportion and the cylinder to the first portion, but it may be appreciatedthat opposite situation where the motor is mounted to the first portionand the cylinder is mounted to the second portion may be provided aswell. The motor may be actuated by an activator, such as a “button” orby another device, such as a wireless device as described above withreference to FIGS. 3a and 3b . Again, in one example, to locate thefirst portion of the housing relative to the second portion of thehousing, the first portion of the body 640 may include a first wall 644extending from the main segment 646 of the first portion or the body. Inaddition, the second portion 642 of the body may include a second wall648 and a support member 650. The first wall 644 may be received in asliding manner between the second wall 648 and the support member 650.

The needles contemplated herein, may include any hollow cylinder orshaft. The needle may include, in some examples, standard bevels, shortbevels, true short bevels, etc. Furthermore, the needles may exhibit anouter diameter in the range of 0.1 mm to 4.6 mm, including all valuesand increments therein. In addition, the needle may exhibit an innerdiameter in the range of 0.08 mm to 4.0 mm, including all values andincrements therein. Furthermore, the needles may exhibit a nominal wallthickness in the range of 0.002 mm to 0.4 mm including all values andincrements therein. The needles may be formed of stainless steel,ceramic composites, or other materials. In addition, the needles or theneedle tips may be replaceable in case of dulling.

As noted earlier, the needle may be positioned within the access portbody in a moving relationship to the chamber or in a fixed relationshipto the chamber. For example, as illustrated in FIGS. 7a and 7b , aneedle 708 may be provided in moving relationship to the chamber 702.The needle may include a latching mechanism to keep the needle frommoving relative to the chamber and may be activated by an actuator. Uponactuation, the needle may be lifted out of the access port body (such asby the action of a magnet) and retained in the open position by a springloaded cam 725. The needle may be held by a spring 724 in the closed orretracted position, keeping the needle from slipping out of the accessport. In other embodiments, such as illustrated in FIGS. 3a and 3b , thelinear traveler provided in the motor 309 may include teeth or threadsthat may hold the needle 308 in place.

Accordingly, a method of injecting a composition into a subject may beprovided using the access port described herein. As alluded to above, acomposition may include pharmaceuticals, nutrients, contrasting agents,blood or its components, etc. Furthermore, a subject may include anyvertebrate or invertebrate, including humans, other mammals, ayes,reptiles, etc. A vascular access port may be implanted into the subjectand the catheter may be inserted into a vein. The needle may be extendedfrom the port upon actuation and may puncture the skin. A compositionmay be introduced to the subject by either injecting the compositioninto the needle or otherwise introducing the needle into a container,such as through a vial stopper. Once administration of the compositionis finished, the needle may be retracted or otherwise positioned backthrough the skin and into the port.

In another example of a method of delivering a composition utilizing avascular access port contemplated herein, a receiver may receive orotherwise detect a first electromagnetic indicator from a transmitter,such as an activator. The indictor may be processed by the receiver toprovide an electrical signal to a processor in electrical communicationwith the receiver. A motor may be activated by the processor once itreceives a signal to activate the motor and the motor may extend orretract the needle with respect to the body of the vascular access portor the motor may collapse or expand the vascular access port withrespect to the needle.

In addition, as may be appreciated herein, the actuator may be providedin direct or indirect communication with the needle and is configured toeither move the needle relative to the access port body or move theaccess port body relative to the needle. Communication may be electricaland/or mechanical, such as that provided by magnetic fields, electricalsignals, mechanical linkages or forces, provided by levers, springs,etc. Furthermore, in instances where the housing may move relative tothe needle, communication may be considered indirect. It may also beappreciated that the actuator may be located outside of the housingbody, located at least partially within the housing body or locatedcompletely within the housing body.

The foregoing description of several methods and embodiments has beenpresented for purposes of illustration. It is not intended to beexhaustive or to limit the claims to the precise steps and/or formsdisclosed, and obviously many modifications and variations are possiblein light of the above teaching. It is intended that the scope of theinvention be defined by the claims appended hereto.

What is claimed is: 1.-20. (canceled)
 21. An access port system,comprising: an implantable access port configured to be implanted into asubject, said access port including an access port body, an access portneedle and a fluid flow passage provided within said access port bodyand said access port needle; wherein said access port needle is fullycontainable within said access port body, and said access port needle isexposable outside said access port body; wherein, when said access portneedle is exposed outside said access port body, said fluid flow passageis open to a flow of a fluid within said access port in at least adirection entering said access port through said access port needle andthereafter exiting said access port through said access port body;wherein said access port needle is arranged within said access port bodyto penetrate outwardly of said subject from within said subject whensaid access port is implanted in said subject; and wherein said assessport includes a communication device and a power supply.
 22. The accessport system of claim 21, wherein said communication device is a wirelesscommunication device.
 23. The access port system of claim 22, whereinsaid wireless communication device comprises at least one of atransmitter, a receiver and a transceiver.
 24. The access port system ofclaim 21, wherein said access port comprises a processor and a memory.25. The access port system of claim 21, further comprising an actuatorconfigured to operate said access port.
 26. The access port system ofclaim 25, wherein said actuator comprises a wireless actuator configuredto communicate wirelessly with said access port.
 27. The access portsystem of claim 25, wherein said actuator is configured to operate of atleast one component within said access port.
 28. The access port systemof claim 27, wherein said at least one component within said access portcomprises a motor.
 29. The access port system of claim 25, wherein saidactuator is configured to move said needle.
 30. The access port systemof claim 25, wherein said actuator is within said access port.
 31. Theaccess port system of claim 25, wherein said actuator is remote fromsaid access port.
 32. The access port system of claim 21, wherein saidaccess port body is configured to collapse from an expanded position toa collapsed position to expose said access port needle outside saidaccess port body and configured to expand from said collapsed positionto said expanded position to contain said access port needle within saidaccess port body.
 33. The access port system of claim 21, wherein saidaccess port needle needle is configured to extend from within saidaccess port body to an extended position to expose said access portneedle outside said access port body and configured to retract into saidaccess port body to a retracted position to contain said access portneedle within said access port body.
 34. The access port system of claim21, wherein said access port needle is mechanically coupled within saidaccess port body to inhibit removal of said access port needle from saidaccess port body.
 35. The access port system of claim 34, wherein saidaccess port needle is mechanically coupled within said access port bodywith positive engagement.
 36. The access port system of claim 21,further comprising a catheter coupled to said access port.